With two years to go before the new REACH laws impact businesses, smaller UK chemical companies have been urged to start preparing now.
REACH – the Registration, Evaluation and Authorisation of Chemicals – requires chemicals which are manufactured in, or imported to, Europe in quantities between 1 and 100 tonnes per year to be registered before 1 June 2018, a change that will mostly, but not exclusively, impact smaller businesses.
The Chemical Industries Association (CIA), which represents chemical manufacturers of all sizes located across the UK, is among organisations which are helping small businesses get ready for the change. As part of the work, the Association’s subsidiary business REACHReady has been working with the UK Government and other organisations to develop joint advice, as well as supporting the European Chemicals Agency in its efforts to raise awareness.
Silvia Segna, CIA’s REACH Executive, said it was crucial that REACH was not put on the back-burner just because there are still two years to comply, adding: “Two years may seem like a long time but it is important that companies start to prepare now. “Waiting till later may lead to chemicals not being able to be registered causing disruption to their manufacture and/or import with potential knock-on effects on businesses and product availability.”
The beginning of REACH can be traced back to 2001, when the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals. Having come into force in 2007, REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.
Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database in the European Chemicals Agency (ECHA) in Helsinki.
The Agency is the central point in the REACH system: it manages the databases necessary to operate the system, co-ordinates the in-depth evaluation of suspicious chemicals and is building up a public database in which consumers and professionals can find hazard information.
Companies are not the only ones being urged to play an active role in REACH. A call for Europe’s different regulatory regimes to engage was made in a major speech delivered in June to Chemspec Europe 2016, the international exhibition for fine and speciality chemicals, by another Chemical Industries Association officer.
Nishma Patel, acting Chemicals Director, urged the world’s regulatory community to embrace early opportunities to influence the fate of chemicals in the EU marketplace and to use REACH to support innovation.
During the speech, Nishma, who leads REACHReady, said “Every chemical business I know appreciates the importance of regulation.
“We are not about de-regulation, indeed we are at Chemspec to make sure businesses know what they need to do to follow the law, but there is scope for businesses to get involved in the REACH processes earlier to ensure both growth and innovation of the EU chemical industry is maintained. Industry must play its part, but so too must regulators.
“I have a message for governments, agencies and others who agree and implement regulation across the globe. Regulate to innovate.”
REACH regulations governing skin sensitivity are changed
The REACH requirements for skin sensitisation are changing, making non-animal testing the default requirement.
The amended REACH annexes concerning skin sensitisation are expected to enter into force in autumn 2016. The information needed for the classification or risk assessment of a substance will then be obtained through non-animal methods as a first step. In vivo methods can only be used if the in chemico or in vitro test methods are not adequate for the substance or cannot be used for classification and risk assessment.
With the amended requirements, if a substance is predicted to be a skin sensitiser based on the available data, skin sensitisation potency should also be assessed. There is currently no standardised way to assess potency with the in vitro methods and, therefore the in vivo test may still be necessary. However, estimating potency is not necessary if an existing in vivo study does not allow potency estimation and the study has been performed according to internationally-adopted test methods and good laboratory practice.
